510(k) · Cleared
Recalled · Class II · 2014Abbott Architect Free T3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · CDP Radioimmunoassay, Total Triiodothyronine
Cleared on Nov 20, 1998 after a 52-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled once.
- Decided
- Nov 20, 1998
- Review
- 52 days
- Class
- Class II
- Product code
- CDP
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK983439 Abbott Architect Free T3Abbott Laboratories · 1998
- Descendant · cites it directly · 0 of its ownK170160 Abbott ARCHITECT Free T3Abbott Laboratories · 2017
Most influential descendants
Showing 1 of 1 · See all- K170160Abbott ARCHITECT Free T3Abbott Laboratories · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983439 | Abbott Architect Free T3 | Abbott Laboratories | 1998 | — |
| +1 | K170160 | Abbott ARCHITECT Free T3 | Abbott Laboratories | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CDP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | AxSYM Free T₃ assay Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170160 | Abbott ARCHITECT Free T3 | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 11, 2014 | Class II | Z-0474-2015 | Employee error | 17% of ARCHITECT Total T3 Reagent Kit, LN 7K64-20/-25 reagent lots 38901UI00 and 38901UI01 may exhibit lower Relative Light Units (RLUs) than expected, which in turn may result in controls out of range or patient results higher than… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K170160 (Abbott Laboratories, 2017) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CDP devicesCDP Radioimmunoassay, Total Triiodothyronine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CDP
FDA has decided no CDP device since 2007.
Median 510(k) review, days · CDP
Too few CDP 510(k)s in any year since 2007 to give a median.
Recalls per year · CDP
3in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CDP
25in 2025
MAUDE reports naming product code CDP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 8 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 2 | 10 |
| 2014 | 0 | — | 1 | 111 |
| 2015 | 0 | — | 1 | 158 |
| 2016 | 0 | — | 0 | 150 |
| 2017 | 0 | — | 1 | 151 |
| 2018 | 0 | — | 3 | 365 |
| 2019 | 0 | — | 0 | 343 |
| 2020 | 0 | — | 0 | 209 |
| 2021 | 0 | — | 0 | 120 |
| 2022 | 0 | — | 0 | 123 |
| 2023 | 0 | — | 0 | 131 |
| 2024 | 0 | — | 0 | 41 |
| 2025 | 0 | — | 0 | 25 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ARCHITECT™ Free T₃ (FT₃) assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (free T₃) in human serum and plasma. The ARCHITECT Free T₃ assay is to be used as an aid in the assessment of thyroid status.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983439 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983439: Abbott Architect Free T3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983439
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026